FDA 510(k)

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

K 號：K162358 · 2016-11-01

決定日期2016-11-01

產品代碼MAX

諮詢委員會OR

決定Substantially Equivalent

器材摘要

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA Products, LLC. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162358. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K162358.

When did T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System receive FDA 510(k) clearance?

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162358.

Who is the listed applicant for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

The FDA 510(k) record lists Synthes USA Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

The FDA product code for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System is MAX.

其他以 Synthes USA Products, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System K212943SyntheCel Dura Repair K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)K210408DePuy Synthes Variable Angle Locking Patella Plating System K210205DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K201346DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

查看所有 30 項裝置 →

相關器械（代碼：MAX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。